COLGATE SPARKLING WHITE MINT ZING- sodium monofluorophosphate paste, dentifrice

Colgate by

Drug Labeling and Warnings

Colgate by is a Otc medication manufactured, distributed, or labeled by Mission Hills, S.A. de C.V.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

Sodium monofluorophosphate 0.76% (0.14% w/v fluoride ion)

Purpose

Anticavity

Use

helps protect against cavities

Warnings

Keep out of reach of children under 6 years of age.

If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

Directions

• adults and children 2 years of age and older: brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or physician
• children 2 to 6 years: use only a pea sized amount and supervise child's brushing and rinsing (to minimize swallowing)
• children under 2 years: ask a dentist or physician

Inactive ingredients

glycerin, hydrated silica, water, sodium bicarbonate, PEG-12, sodium lauryl sulfate, flavor, sodium hydroxide, cellulose gum, carrageenan, sodium saccharin, calcium peroxide, titanium dioxide, FD&C green no. 3

Questions?

1-800-468-6502

SPL UNCLASSIFIED SECTION

Dist. by:
COLGATE-PALMOLIVE COMPANY
New York, NY 10022

PRINCIPAL DISPLAY PANEL - 232 g Tube Carton

Colgate®
Fluoride Toothpaste

Mint Zing

Paste

SPARKLING
WHITE®
with Baking Soda & Peroxide

WHITENS & PROTECTS TEETH FROM STAINS

NET WT 8.2 OZ (232 g)

INGREDIENTS AND APPEARANCE

COLGATE   SPARKLING WHITE MINT ZING
sodium monofluorophosphate paste, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 65954-007
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM MONOFLUOROPHOSPHATE (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O)	SODIUM MONOFLUOROPHOSPHATE	7.6 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)	491.6 mg  in 1 g
HYDRATED SILICA (UNII: Y6O7T4G8P9)
WATER (UNII: 059QF0KO0R)
SODIUM BICARBONATE (UNII: 8MDF5V39QO)
POLYETHYLENE GLYCOL 600 (UNII: NL4J9F21N9)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)
CARRAGEENAN (UNII: 5C69YCD2YJ)
SACCHARIN SODIUM DIHYDRATE (UNII: SB8ZUX40TY)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FD&C GREEN NO. 3 (UNII: 3P3ONR6O1S)

Product Characteristics
Color	BLUE, WHITE	Score
Shape		Size
Flavor	PEPPERMINT	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 65954-007-82	1 in 1 CARTON
1		232 g in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part355	08/20/2011

Labeler - Mission Hills, S.A. de C.V. (812312122)